DFIS Eden Medical, Inc. is pleased to submit this revised Phase 2 SBIR proposal to develop the infrared Diabetic Foot Imaging Scanner (DFIS) to demonstrate the ability to capture dynamic thermal imagery and identify hot spots associated with repetitive stress. Diabetic foot wounds are common, complex and costly. Foot areas that are likely to ulcerate are associated with increased local skin temperature due to inflammation and enzymatic autolysis of tissue. Inflammation is characterized by the cardinal signs of: degree of redness, swelling, and heat. The key focus of DFIS imaging is to provide the capability to quantify all three signs of inflammation and identify pathological changes before they result in ulceration. The key goals of the proposed Phase 2 project are to: 1) to demonstrate the ability to capture dynamic thermal imagery of the feet, identify hot spots and inflammatory patterns in patients with diabetes; 2) to assess the quantification of wound healing using wound inflammatory index (Wii), a thermal index for diabetic foot wounds; 3) to associate the temporal behavior of Wii (quantified during wound healing) with 4 degree F home monitoring criteria for temperature differences between contra lateral sites on both feet during risk assessment phase with the intent to reduce ulceration risk. PUBLIC HEALTH RELEVANCE: To develop a point-of-care infrared imaging system that scans around the foot of a diabetic patient to assess and associate patterns of inflammation to reduce risk of ulceration.